NCT06749444 (COSTS) is a NA clinical trial of CBT-I in Treatment-refractory Schizophrenia, sponsored by Jimmi Nielsen.

Who is sponsoring NCT06749444?

NCT06749444 is sponsored by Jimmi Nielsen.

What drugs are being tested in NCT06749444?

Interventions in NCT06749444: CBT-I, CBT.

What condition does NCT06749444 study?

NCT06749444 studies Treatment-refractory Schizophrenia, Treatment-resistant Schizophrenia.

Is NCT06749444 still recruiting?

NCT06749444 is currently recruiting now. Last updated 20 January 2026.

Last reviewed 2026-01-20 · How we verify

NCT06749444: COSTS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia

Recruiting now NA Last updated 20 January 2026

What this trial tests

NA trial testing CBT-I in Treatment-refractory Schizophrenia in 60 participants. Currently enrolling.

Timeline

28 November 2024

Primary endpoint
30 June 2026

30 April 2027

Quick facts

Lead sponsor	Jimmi Nielsen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	28 November 2024
Primary completion	30 June 2026
Estimated completion	30 April 2027
Sites	1 location across Denmark

Drugs / interventions tested

CBT-I
CBT — full drug profile →

Conditions studied

Treatment-refractory Schizophrenia — all drugs for Treatment-refractory Schizophrenia →
Treatment-resistant Schizophrenia — all drugs for Treatment-resistant Schizophrenia →

Sponsor

Jimmi Nielsen

Who can join

Adults 18 to 64, any sex, with Treatment-refractory Schizophrenia or Treatment-resistant Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life. We are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session/week. After 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Cognitive behavioral therapy for insomnia vs. standard cognitive behavioral therapy for sleep and circadian disturbances in treatment-resistant schizophrenia: study protocol for the randomized controlled trial (COSTS).
Johansen JF, Nielsen MØ, Kragh M, Nielsen J. · · 2026 · PMID 41998739 · DOI 10.1186/s13063-026-09482-0

Verify or expand the search:

Other trials of CBT-I

Trials testing the same drug.

NCT07333586 — Insomnia and Insulin Resistance · NA · not yet recruiting
NCT07279168 — Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Canc · NA · not yet recruiting
NCT07091149 — Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy o · NA · recruiting
NCT06156306 — CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety · NA · recruiting
NCT06054243 — Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia · NA · recruiting

Other Jimmi Nielsen trials

Trials by the same sponsor.

NCT05316883 — Biomarkers in Clozapine-responding Schizophrenia · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06749444 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jimmi Nielsen
Last refreshed: 20 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06749444.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing